PROMETRIUM ® - Progesterone

PROMETRIUM ® is a drug based on micronized Progesterone

THERAPEUTIC GROUP: Progestinic

IndicationsAction mechanismStudies and clinical effectiveness Usage and dosage instructionsWarnings Pregnancy and lactationInteractionsContraindicationsUndesirable effects

Indications PROMETRIUM ® - Progesterone

PROMETRIUM ® can be used effectively systemically in the treatment of premenstrual syndrome, in cycle alterations and as a hormone replacement therapy combined with estrogen.

The vaginal assumption, which guarantees a greater concentration of the active ingredient at the vaginal and uterine levels, is instead indicated as an adjuvant of the luteinic phase during spontaneous or induced cycles, in the case of a threat of abortion or in the prevention of abortions linked to insufficiency of the luteinic phase .

Mechanism of action PROMETRIUM ® - Progesterone

The particular formulation of PROMETRIUM ® in soft capsules allows a dual use of the drug with important differences relating to the pharmacokinetic properties.

Oral administration in fact allows the achievement of the maximum plasma progesterone concentrations after about 3 hours from the oral intake which remain elevated for about 12 hours, while the vaginal one presents a delayed peak over time with lower plasma concentrations than the oral one, but with a particularly intense activity at the uterine level.

In both cases the progesterone is eliminated in the form of glucoronate metabolites mainly through the urine, after carrying out its own biological action.

The latter takes the form of induction and maintenance of the endometrial secretory phase, useful for guaranteeing the appropriate cellular and histological transformations necessary to favor the nesting of the embryo and correct growth.

Progesterone therapy during menopause is instead necessary to reduce some of the most important side effects of hormone replacement therapy with estrogens such as hyperplasia and proliferation of endometrial cells, responsible for increasing the number of endometrial carcinomas.

Studies carried out and clinical efficacy

1. PROMETRIUM AND MENOPAUSAL SYMPTOMS

The arrival of the knobs is often accompanied by a particularly annoying symptomatology characterized by vasomotor and neurological disorders. The vaginal administration of prometrium combined with the transdermal administration of estrogen has been shown to be effective in controlling the aforementioned symptoms, reducing the appearance of particularly serious side effects.

2. PROGESTERONE AND ANSWER TO THE STRESS

3. ESTROGENES AND PROGESTERONE IN METABOLIC CONTROL

Interesting study that has shown that the concomitant intake of micronized progesterone and estrogen, among other effects, can significantly reduce LDL cholesterol concentrations and increase HDL concentrations. This important lipidemic control combined with an improvement of the glucidic one could prove important on the long-term effects of the substitution therapy.

Method of use and dosage

PROMETRIUM ® soft capsules of 100 - 200 mg of micronized progesterone:

although from the pharmacokinetic point of view oral and vaginal progesterone intake have different characteristics and although the therapeutic indications of the two methods of administration differ significantly, the recommended dosage seems to be more or less standard.

In most cases, and in the various therapeutic indications, the intake of 200-300 mg daily, far from meals and preferably divided into doses to be taken every 12 hours, seems to satisfy all the different needs.

However, it is clear that the correct dosage must be formulated by your doctor after a careful evaluation of the physiopathological situation and of the relative clinical picture.

Warnings PROMETRIUM ® - Progesterone

Therapy with PROMETRIUM ® must necessarily be preceded by a careful gynecological examination useful to verify the real need for its administration and the possible presence of risk factors capable of complicating therapy.

Patients suffering from embolic thrombus processes or alterations in cardiovascular function, recurrent cholestasis, reduced hepatic and renal function, epilepsy and neuro-psychiatric disorders, breast lumps or pathologies, diabetes mellitus, lupus and autoimmune diseases, should be carefully supervised throughout the course of therapy and subjected to periodic checks.

The doctor must also inform the patient about the possible consequences of progestin therapy, such as the increased risk of developing breast carcinomas, especially when combined with estrogen in the treatment of complex post-climacteric symptoms.

Some side effects of progestogen therapy such as headache, migraine and drowsiness may make it dangerous to use machinery and drive vehicles after taking PROMETRIUM ®

PREGNANCY AND BREASTFEEDING

The use of micronized progesterone during pregnancy is allowed only in the first trimester of pregnancy when the corpus luteum cannot guarantee the correct secretion of this hormone at concentrations useful for the nesting and growth of the embryo.

PROMETRIUM ® should not be administered beyond the first trimester of pregnancy and during the lactation period given the ability of its active ingredient to easily pass through the breast filter concentrating in breast milk.

Interactions

Given the important hepatic metabolism of progesterone, supported by the enzymatic class CyP450, the simultaneous intake of active ingredients capable of modulating the activity of the aforementioned enzymes could determine important pharmacokinetic variations and in some cases worthy of clinical interest.

Anticoagulants, antidepressants, antibiotics, analgesics and barbiturates represent only some of the active ingredients for which particular attention should be paid.

If PROMETRIUM ® is taken vaginally, it would be necessary to avoid the concomitant intake of other products for vaginal use, in order to reduce possible side effects on the vaginal mucosa.

PROMETRIUM ® Contraindications - Progesterone

PROMETRIUM ® is contraindicated in case of hypersensitivity to the active substance or to one of its excipients, in case of vaginal bleeding of unknown origin, breast cancer or estrogen-progestin dependent tumors, changes in liver and kidney function, existing or previous thromboembolic processes.

Undesirable effects - Side effects

Progesterone therapy is decidedly better tolerated than with estrogen, especially if performed with capsules or gels for vaginal use.

Among the side effects most complained of by patients subjected to therapy and more described in the scientific literature it is possible to remember: drowsiness, migraine, depression, changes in menstrual flow, amenorrhea, metrorrhagia, weight changes, increase in volume and breast tenderness, rash and local irritations.